Coaptation enhancement implant, system, and method

ABSTRACT

Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.

This application is a continuation of U.S. patent application Ser. No.16/675,565, filed Nov. 6, 2019 and currently pending, which in turn is ais a continuation of U.S. patent application Ser. No. 15/475,629, filedMar. 31, 2017 now U.S. Pat. No. 10,470,883, which in turn is acontinuation of U.S. patent application Ser. No. 14/500,470, filed Sep.29, 2014, now U.S. Pat. No. 9,610,163, which in turn is a continuationof U.S. patent application Ser. No. 13/099,532, filed May 3, 2011, nowU.S. Pat. No. 8,845,717, which in turn claims priority to provisionalU.S. Patent Application No. 61/437,397, titled “Coaptation EnhancementImplant, System, and Method” and filed Jan. 28, 2011. The entiredisclosure of each of the foregoing priority applications is herebyincorporated by reference herein for all purposes.

BACKGROUND OF THE INVENTION

The present invention generally provides improved medical devices,systems, and methods, typically for treatment of heart valve diseaseand/or for altering characteristics of one or more valves of the body.Exemplary embodiments of the invention include implants for treatment ofmitral valve regurgitation.

The human heart receives blood from the organs and tissues via theveins, pumps that blood through the lungs where the it becomes enrichedwith oxygen, and propels the oxygenated blood out of the heart to thearteries so that the organ systems of the body can extract the oxygenfor proper function. Deoxygenated blood flows back to the heart where itis once again pumped to the lungs.

As can generally be seen in FIGS. 1A and 1B, the heart includes fourchambers: the right atrium (RA), the right ventricle (RV), the leftatrium (LA) and the left ventricle (LV). The pumping action of the leftand right sides of the heart occurs generally in synchrony during theoverall cardiac cycle.

The heart has four valves generally configured to selectively transmitblood flow in the correct direction during the cardiac cycle. The valvesthat separate the atria from the ventricles are referred to as theatrioventricular (or AV) valves. The AV valve between the left atriumand the left ventricle is the mitral valve. The AV valve between theright atrium and the right ventricle is the tricuspid valve. Thepulmonary valve directs blood flow to the pulmonary artery and thence tothe lungs; blood returns to the left atrium via the pulmonary veins. Theaortic valve directs flow through the aorta and thence to the periphery.There are normally no direct connections between the ventricles orbetween the atria.

The mechanical heartbeat is triggered by an electrical impulse whichspreads throughout the cardiac tissue. Opening and closing of heartvalves may occur primarily as a result of pressure differences betweenchambers, those pressures resulting from either passive filling orchamber contraction. For example, the opening and closing of the mitralvalve may occur as a result of the pressure differences between the leftatrium and the left ventricle.

At the beginning of ventricular filling (diastole) the aortic andpulmonary valves are closed to prevent back flow from the arteries intothe ventricles. Shortly thereafter, the AV valves open to allowunimpeded flow from the atria into the corresponding ventricles. Shortlyafter ventricular systole (i.e., ventricular emptying) begins, thetricuspid and mitral valves normally shut, forming a seal which preventsflow from the ventricles back into the corresponding atria.

Unfortunately, the AV valves may become damaged or may otherwise fail tofunction properly, resulting in improper closing. The AV valves arecomplex structures that generally include an annulus, leaflets, chordaeand a support structure. Each atrium interfaces with its valve via anatrial vestibule. The mitral valve has two leaflets; the analogousstructure of the tricuspid valve has three leaflets, and apposition orengagement of corresponding surfaces of leaflets against each otherhelps provide closure or sealing of the valve to prevent blood flowingin the wrong direction. Failure of the leaflets to seal duringventricular systole is known as malcoaptation, and may allow blood toflow backward through the valve (regurgitation). Heart valveregurgitation can have serious consequences to a patient, oftenresulting in cardiac failure, decreased blood flow, lower bloodpressure, and/or a diminished flow of oxygen to the tissues of the body.Mitral regurgitation can also cause blood to flow back from the leftatrium to the pulmonary veins, causing congestion. Severe valvularregurgitation, if untreated, can result in permanent disability ordeath.

A variety of therapies have been applied for treatment of mitral valveregurgitation, and still other therapies may have been proposed but notyet actually used to treat patients. While several of the knowntherapies have been found to provide benefits for at least somepatients, still further options would be desirable. For example,pharmacologic agents (such as diuretics and vasodilators) can be usedwith patients having mild mitral valve regurgitation to help reduce theamount of blood flowing back into the left atrium. However, medicationscan suffer from lack of patient compliance. A significant number ofpatients may occasionally (or even regularly) fail to take medications,despite the potential seriousness of chronic and/or progressivelydeteriorating mitral valve regurgitation. Pharmacological therapies ofmitral valve regurgitation may also be inconvenient, are oftenineffective (especially as the condition worsens), and can be associatedwith significant side effects (such as low blood pressure).

A variety of surgical options have also been proposed and/or employedfor treatment of mitral valve regurgitation. For example, open-heartsurgery can replace or repair a dysfunctional mitral valve. Inannuloplasty ring repair, the posterior mitral annulus can be reduced insize along its circumference, optionally using sutures passed through amechanical surgical annuloplasty sewing ring to provide coaptation. Opensurgery might also seek to reshape the leaflets and/or otherwise modifythe support structure. Regardless, open mitral valve surgery isgenerally a very invasive treatment carried out with the patient undergeneral anesthesia while on a heart-lung machine and with the chest cutopen. Complications can be common, and in light of the morbidity (andpotentially mortality) of open-heart surgery, the timing becomes achallenge-sicker patients may be in greater need of the surgery, butless able to withstand the surgery. Successful open mitral valvesurgical outcomes can also be quite dependent on surgical skill andexperience.

Given the morbidity and mortality of open-heart surgery, innovators havesought less invasive surgical therapies. Procedures that are done withrobots or through endoscopes are often still quite invasive, and canalso be time consuming, expensive, and in at least some cases, quitedependent on the surgeon's skill. Imposing even less trauma on thesesometimes frail patients would be desirable, as would be providingtherapies that could be successfully implemented by a significant numberof physicians using widely distributed skills. Toward that end, a numberof purportedly less invasive technologies and approaches have beenproposed. These include devices which seek to re-shape the mitralannulus from within the coronary sinus; devices that attempt to reshapethe annulus by cinching either above to below the native annulus;devices to fuse the leaflets (imitating the Alfieri stitch); devices tore-shape the left ventricle, and the like. Perhaps most widely known, avariety of mitral valve replacement implants have been developed, withthese implants generally replacing (or displacing) the native leafletsand relying on surgically implanted structures to control the blood flowpaths between the chambers of the heart. While these various approachesand tools have met with differing levels of acceptance, none has yetgained widespread recognition as an ideal therapy for most or allpatients suffering from mitral valve regurgitation.

Because of the challenges and disadvantages of known minimally invasivemitral valve regurgitation therapies and implants, still furtheralternative treatments have been proposed. Some of the alternativeproposals have called for an implanted structure to remain within thevalve annulus throughout the heart beat cycle. One group of theseproposals includes a cylindrical balloon or the like to remain implantedon a tether or rigid rod extending between the atrium and the ventriclethrough the valve opening. Another group relies on an arcuate ringstructure or the like, often in combination with a buttress orstructural cross-member extending across the valve so as to anchor theimplant. Unfortunately, sealing between the native leaflets and the fullperimeter of a balloon or other coaxial body may prove challenging,while the significant contraction around the native valve annulus duringeach heart beat may result in significant fatigue failure issues duringlong-term implantation if a buttress or anchor interconnecting crossmember is allowed to flex. Moreover, the significant movement of thetissues of the valve may make accurate positioning of the implantchallenging regardless of whether the implant is rigid or flexible.

In light of the above, it would be desirable to provide improved medicaldevices, systems, and methods. It would be particularly desirable toprovide new techniques for treatment of mitral valve regurgitation andother heart valve diseases, and/or for altering characteristics of oneor more of the other valves of the body. The need remains for a devicewhich can directly enhance leaflet coaptation (rather than indirectlyvia annular or ventricular re-shaping) and which does not disruptleaflet anatomy via fusion or otherwise, but which can be deployedsimply and reliably, and without excessive cost or surgical time. Itwould be particularly beneficial if these new techniques could beimplemented using a less-invasive approach, without stopping the heartor relying on a heart-lung machine for deployment, and without relyingon exceptional skills of the surgeon to provide improved valve and/orheart function.

SUMMARY OF THE INVENTION

The present invention generally provides improved medical devices,systems, and methods. In exemplary embodiments, the invention providesnew implants, implant systems, and methods for treatment of mitral valveregurgitation and other valve diseases. The implants will generallyinclude a coaptation assist body which remains within the blood flowpath as the leaflets of the valve move back and forth between anopen-valve configuration and a closed valve configuration. The exemplarycoaptation assist bodies or valve bodies may be relatively thin,elongate (along the blood flow path), and/or conformable structureswhich extend laterally across some, most, or all of the width of thevalve opening, allowing the native leaflets to engage and seal againstthe opposed surfaces on either side of the valve body. To allow safe andeffective, long-term operation of the valve tissue, the valve body maybe laterally offset from the centroid of the overall valve, and/or maycurve laterally across the valve opening so as to mimic the natural,pre-treatment geometry of the coaptation zone directly between the twonative mitral valve leaflets. The presence of the valve body between thenative leaflets can enhance sealing by filling gaps between themal-coapting leaflet surfaces, and/or the implanted valve body can allowthe leaflets to coapt with axially offset regions of the opposedcoaptation surfaces of the valve body.

Though the valve body will generally remain within the blood flow pathof the valve (typically with blood passing on either side of the valvebody during diastole), the valve body may move and/or deformsignificantly to help maintain natural movement of the heart tissues. Asthe valve opens during diastole, the valve body may move somewhat withthe flow, somewhat like a middle leaflet or sail around which the bloodpasses, as well as with movement of the heart tissues to which the valvebody is mounted. As the valve moves from the open configuration towardthe closed configuration, the movement of the native valve leaflettissue, valve-body support tissues (to which the valve body isanchored), and blood within the heart may help to move the valve bodyback into a desirable configuration for sealing. Surprisingly, separatedeployment of independent anchors near each of the two commissures maygreatly facilitate and expedite accurate positioning and support of thevalve body, with an exemplary triangular valve body employing a thirdanchor between the papillary muscles (or otherwise within theventricle). The exemplary valve body includes an outer surfacecomprising ePTFE or other biocompatible and non-thrombogenic materials,ideally formed as a layer over a fluid absorbing foam or other matrixthat swells toward a desired nominal three-dimensional valve body shapeafter introduction into the heart, with the valve body shape optionallybeing selected after one or more of the anchors has been deployed.Advantageously, the implants described herein can be placed into apatient's beating heart and accurately positioned in alignment with themitral valve without open heart surgery, typically via a patient'svasculature and/or using minimally invasive surgical techniques, andoften using a catheter deployment system having a desirably smallprofile. Hence, the invention can provide simple, cost-effective, andless invasive devices, systems, and methods for treating a range ofdysfunction of a heart valve, e.g., in the treatment of organic andfunctional mitral valve regurgitation.

In a first aspect, the invention provides a method for treatingmal-coaptation of a heart valve in a patient. The heart valve has anannulus and first and second leaflets. The annulus defines a valve axisextending along a blood flow path, and the first and second leafletshave a coaptation zone defining a curve extending across the flow path.The method comprises introducing an implant into the heart while theimplant is in a first configuration. The implant is deployed from thefirst configuration to a second configuration within the heart. Theimplant in the second configuration has a coaptation assist body withfirst and second opposed coaptation surfaces. The deployed implant issupported so that the coaptation assist body is offset from the axis ofthe heart valve along the coaptation zone. The first leaflet of theheart valve seals or coapts with the first coaptation surface and thesecond leaflet of the heart valve seals or coapts with the secondcoaptation surface such that the mal-coaptation of the heart valve ismitigated.

In another aspect, the invention provides a method for treatingmal-coaptation of a heart valve in a patient. The heart valve has firstand second leaflets with a first commissure at a first junction of thefirst and second leaflets and a second commissure at a second junctionof the first and second leaflets. The method comprises selectivelydeploying a first anchor at a first target location near the firstcommissure. A second anchor is selectively deployed at a second targetlocation near the second commissure. A coaptation assist body isintroduced into the heart, the coaptation assist body having first andsecond opposed coaptation surfaces. The coaptation assist body issupported with the first anchor so that a first lateral edge of thecoaptation assist body extends toward the first commissure, and thecoaptation assist body is supported with the second anchor so that asecond lateral edge of the coaptation assist body extends toward thesecond commissure. The first leaflet of the heart valve coapts with thefirst coaptation surface and the second leaflet of the heart valvecoapts with the second coaptation surface such that the mal-coaptationof the heart valve is mitigated

In an apparatus aspect, the invention provides an implant for treatingmal-coaptation of a heart valve in a patient. The heart valve has anannulus and first and second leaflets with a first commissure at a firstjunction of the first and second leaflets and a second commissure at asecond junction of the first and second leaflets. The implant comprisesa coaptation assist body having an axis and first and second opposedmajor coaptation surfaces. Each coaptation surface extends laterallybetween a first lateral edge and a second lateral edge of the coaptationassist body. A first anchor is selectively deployable at a first targetlocation of the heart near the first commissure and coupleable to thecoaptation assist body so that the first lateral edge is oriented towardthe first commissure. A second anchor is selectively deployable,independently of the deployment of the first anchor, at a second targetlocation of the heart near the second commissure, and is coupleable withthe coaptation assist device so that the second lateral edge is orientedtoward the second commissure, such that the first leaflet of the heartvalve coapts with the first coaptation surface and the second leaflet ofthe heart valve coapts with the second coaptation surface sufficientlythat the mal-coaptation of the heart valve is mitigated

In another device aspect the invention provides a coaptation assistimplant for treating mal-coaptation of a heart valve in a patient. Theheart valve has an annulus and first and second leaflets, the annulusdefining a valve axis extending along a blood flow path. The first andsecond leaflets have a coaptation zone defining a curve extending acrossthe flow path. The implant comprises a coaptation assist body having anaxis and first and second opposed major coaptation surfaces. Eachcoaptation surface extends laterally between a first lateral edge and asecond lateral edge of the coaptation assist body. The coaptation assistbody is supportable within the heart so that the axis of the implantextends along the axis of the valve with the first and second lateralsides of the coaptation assist body extend along the curve of thecoaptation zone of the heart valve. The coaptation assist body of thesupported implant is sufficiently laterally conformable that engagementbetween the implant and the heart laterally bends the coaptation assistbody between the edges toward the curve defined by the coaptation zoneof the heart valve

In yet another device aspect, the invention provides a coaptation assistimplant for treating mal-coaptation of a heart valve in a patient. Theheart valve has an annulus and first and second leaflets, the annulusdefining a valve axis extending along a blood flow path. The first andsecond leaflets have a coaptation zone defining a curve extending acrossthe flow path. The implant comprises a coaptation assist body having anaxis and first and second opposed major coaptation surfaces. Eachcoaptation surface extends laterally between a first lateral edge and asecond lateral edge of the coaptation assist body. The coaptation assistbody is introducible into the heart and supportable within the heart sothat the axis of the coaptation assist body extends along the axis ofthe valve with the first and second lateral sides of the coaptationassist body extending, fully or partially, along the curve of thecoaptation zone of the heart valve. The coaptation assist body isdeployable from a first configuration to a second configuration byremoving the coaptation assist body from within a surrounding deploymentcatheter.

In a system aspect, the invention provides a coaptation assist systemfor treating malcoaptation of a heart valve in a patient. The heartvalve has an annulus and first and second leaflets. The annulus definesa valve axis extending along a blood flow path. The system comprises adeployment catheter system including a catheter body having a proximalend and a distal end. The distal end is steerable within the heart fromthe proximal end. A first anchor is selectively deployable from thedistal end of the catheter body at a first target location of the heartnear the first commissure. A coaptation assist body has an axis andfirst and second opposed major coaptation surfaces. Each coaptationsurface extends laterally between a first lateral edge and a secondlateral edge of the coaptation assist body. The coaptation assist bodyis introducible into the heart and coupleable in vivo with the firstanchor after the first anchor is deployed in the heart so that the firstlateral edge extends toward the first commissure.

In exemplary embodiments, a second anchor may be selectively deployableat a second target location, and a distal ventricular anchor may beselectively deployable at a third target locations, the selection of thetarget locations ideally being substantially independent of each other.Optionally, in vivo coupling of the coaptation assist body to the secondanchor orients the second lateral edge toward the second commissure,while the distal ventricular anchor may optionally be mounted to thecoaptation assist body prior to introduction into the patient and usedto help orient the coaptation assist body. In many embodiments thecoaptation assist body of the supported implant will define a curveextending across the blood flow path of the valve. The curve of thecoaptation assist body can corresponding to the curve of the coaptationzone. Optionally, the engagement between the implant and the tissue ofthe heart may orient and maintain a position of the coaptation assistbody so that the curves correspond. The implant will often be deployedand supported within the heart so that along the coaptation zone thefirst surface has a curved cross-section and the second surface has acurved cross-section, and so that coaptation assist body, including thecurved cross-sections of the first and second surfaces, is separatedfrom and curves around the central axis of the heart valve. The implantcan be deployed and supported within the heart so that along thecoaptation zone the first surface has a concave cross-section and thesecond surface has a convex cross-section, and so that the concavecross-section of the first surface is separated from and curves aroundthe axis of the heart valve.

In another device aspect, a coaptation assist device for treatingmal-coaptation of a heart valve in a patient is provided. The heartvalve has an annulus and first and second leaflets. The annulus definesa valve axis, and the first and second leaflets have a coaptation zone.The device comprises a coaptation assist body having an axis and firstand second opposed major coaptation surfaces. The coaptation assist bodydefines a channel within the coaptation assist body, and the coaptationassist body is introducible into the heart and coupleable in vivo withinthe heart valve. The device further comprises a tether disposed withinthe axial channel and coupled to the coaptation assist body near a firstend of the channel, and also comprises a curvature lock attached to thetether near a second end of the channel. The tether is lockable by thelock to constrain the distance between the first and second ends of thechannel so as to define a curvature of the coaptation assist body.

In another method aspect, a method of treating mal-coaptation of a heartvalve in a patient is provided. The heart valve has an annulus and firstand second leaflets. The annulus defines a valve axis extending along ablood flow path, and the first and second leaflets have a coaptationzone. The method comprises introducing an implant having a coaptationassist body with first and second opposed coaptation surfaces into theheart valve, supporting the deployed implant so that the coaptationassist body is disposed within the coaptation zone, and adjusting acurvature of the coaptation assist body.

In another system aspect, a system for treating mal-coaptation of aheart valve in a patient is provided. The heart valve has an annulus andfirst and second leaflets, and the annulus defines a valve axis. Thesystem comprises a catheter system including a catheter body having aproximal end and a distal end, and the distal end is steerable withinthe heart from the proximal end. The system further comprises acoaptation assist body having an axis and first and second opposed majorcoaptation surfaces. Each of the coaptation surfaces extends laterallybetween a first lateral edge and a second lateral edge of the coaptationassist body. The coaptation assist body is introducible into the heartand coupleable in vivo within the heart valve, and the coaptation assistbody defines a channel. The system further includes a tether extendingthrough the channel such that a curvature of the coaptation assist bodyis adjustable by varying the distance between the ends of the channelalong the tether. The system also comprises a curvature lock on thetether operable to constrain the distance between the ends of thechannel so as to define a curvature of the coaptation assist body.

Advantageously, engagement between the implant and the heart valve(optionally including engagement between the coaptation assist body andthe leaflets) can induce conformation of the curve of the coaptationassist body to the curve defined by the coaptation zone of the heartvalve. More specifically, the coaptation zone of the heart valve mayhave a pre-treatment coaptation zone and the coaptation zone may exhibita pre-treatment curve across the valve annulus. Engagement of the heartvalve against the implant can laterally bend the coaptation assist bodyfrom a nominal cross-sectional shape toward the pre-treatment curve.Note that lateral flexibility of the coaptation assist body may be quitehigh (some embodiments relying on a single sheet of relatively thinmembrane along at least a portion of the body, optionally with themembrane being supported at opposed edges and without lateralreinforcement against lateral bending), and that the bending forces willoften be imposed at least in part via the anchoring structures (and/orvia the direct engagement between the native leaflets of the valve andthe coaptation assist body). Where the first leaflet may coapt with thefirst coaptation surface along a first axial coaptation range, and thesecond leaflet may coapt with the second coaptation surface along asecond axial coaptation range at least partially offset from the firstcoaptation range, the coaptation assist body will preferably havesufficient axial stiffness to inhibit axial flexing when the first andsecond axial coaptation ranges are offset such that regurgitationassociated with prolapse is inhibited. For example, axially orientedstiffeners may extend along an axial length of the coaptation body. Inmany embodiments, the axial stiffness of the coaptation assist body willbe greater than a lateral stiffness of the coaptation assist body, suchthat engagement of the leaflets of the valve against the coaptationassist body laterally bends the coaptation assist body with limitedaxial bending of the coaptation assist body, optionally through the useof axial stiffeners, supporting of the coaptation assist body under anaxial load, or the like.

Embodiments of the coaptation assist body and methods for its use maybenefit from relatively simple and readily deployed shapes. In someembodiments, the implant can be deployed and supported within the heartso that downstream of the coaptation zone the coaptation assist bodydefines a downstream curve, the downstream curve having a radius smallerthan the curve of the coaptation assist body along the coaptation zonethis provides the coaptation assist body with a funnel-like shape. Alateral width of the coaptation assist body adjacent the annulus may beconfigured to extend only part way between the commissures during someor all of the heart beat cycle. As the commissure-to-commissure width ofthe valve may decrease significantly from diastole to systole, havingthe width of the coaptation assist body being less than thecommissure-to-commissure width may help limit disadvantageous bending ofthe coaptation assist body during cardiac cycles. Some embodiments mayemploy coaptation assist bodies having a first lateral width adjacentthe annulus that is configured for sealingly engaging against the valveat the first commissure and at the second commissure. The coaptationassist body of the supported implant can taper axially inwardlydownstream of the coaptation zone so that a downstream width of thecoaptation assist body is less than the first width, with the downstreamend preferably being rigidly or resiliently supported by a third anchordeployed in the ventricle of the heart. Where the coaptation assist bodycomprises a conformable material such as ePTFE, such a triangularstructure may be constrained in a relatively small diameter catheter andeasily and accurately deployed within the valve using plasticallydeformable polymers or the like, often without having to rely on exoticresilient flexible structural shapes or being subject to fatiguefailures related to the significant changes in size of the valve annulusduring beating of the heart.

A variety of known or new support structures can be used to support thecoaptation assist body within the valve of the heart. In exemplaryembodiments, a first lateral edge of the coaptation assist body will besupported with a first support interface adjacent the first commissure.A second lateral edge of the coaptation assist body can similarly besupported with a second support interface adjacent the secondcommissure. Each of the first and second support interfaces shouldideally be able to transmit loads between the coaptation assist body andtissue of the heart so as to maintain a desired position of the implantwhen the annulus of the heart changes in diameter by more than 10% witheach beat of the heart, typically by more than 15%, and ideally by about20% or more. While some embodiment may employ arcuate support structuresextending around the valve annulus or structural interconnects whichseek to resiliently or rigidly span the annulus (optionally so as pressoutwardly against opposed regions of the annulus during at least aportion of heart beat cycle), preferred approaches will avoid thelimitations on cardiac tissue movement and/or limits to fatigue life ofthe implant that may result. By instead employing functionally separateanchor structures near each commissure, which anchors can beindependently deployed (and if desired, independently removed andrepositioned), these embodiments present significant structuraladvantages without having to limit tissue movement or implant life.

Exemplary embodiments of the structural interfaces supporting thecoaptation assist body may include a tissue penetrating body that can beadvanced from within a chamber of the heart into a tissue of the heart.For example, the interface may employ a helical body having a helicalaxis, so that advancing of the helical body into the tissue of the heartcan be performed by rotating the helical body about the helical axis soas to screw the helical body into a tissue of the heart adjacent theannulus. When the interface relies on an annular support structureadjacent the annulus, at least one of the support interfaces maycomprise a sliding interface between the annular support structure andthe coaptation assist body so as to accommodate tissue motion withoutlimiting fatigue life. An apical end of the coaptation assist body mayextend axially from the annulus toward a ventricular apex of the heart,and the apical end of the coaptation assist body can be supportedrelative to a ventricular tissue of the heart with a ventricular supportinterface such as an anchor deployed between the papillary muscles. Theapical end of the coaptation assist body can be affixed to atissue-engaging surface of the anchor or other ventricular supportinterface, or a resilient (including superelastic) structure such as aspring, elastic fabric, metal coil, or the like may alternativelyresiliently support the apical end of the coaptation assist bodyrelative to a tissue engaging surface of the ventricular supportinterface so as to support the implant throughout changes in axiallength of the ventricle during beating of the heart. Although optionalembodiments might include a shaft or other structural member extendingfrom tissues of the ventricle toward the atrium so as to axiallymaintain the coaptation assist body up within the coaptation zone, manyembodiments can forego such compressively loaded structures.

The relative sizes and shapes of the coaptation assist bodies may beselected in response to characterization of the mal-coaptation of aparticular patient's mitral valve, in response to valve measurements,and/or the like, but will often include certain common characteristicsthat enhance the functioning and/or deployment of the implant. When theimplant is in a nominal configuration (such as when the coaptationassist device is unconstrained and at rest within blood or anothersuitable fluid) the coaptation assist body may have an axial length, athickness between the coaptation surfaces, and acommissure-to-commissure width. Similarly, when the implant is deployed,coaptation assist device may similarly have an axial length, athickness, and a width. When the implant is in the nominal and/ordeployed configuration the width may be from 5 mm to 35 mm, typicallybeing about 20 mm. Preferably, when the implant is in the nominal and/ordeployed configuration the thickness will typically be from 0.5 mm to 10mm, preferably being about 3 mm; and in many cases less than 20% of thewidth, often less than 15% of the width, optionally being less than 10%of the width. In many embodiments, when in the nominal and/or deployedconfiguration, the length will be from 20 mm to 60 mm, preferably beingabout 40 mm; and generally at least 75% of the width, typically being atleast 150% of the width, and in many cases being at least 175% or evenat least 200% of the width. The commissure-to-commissure width of thecoaptation assist body can be less than a measuredcommissure-to-commissure width of the patient's valve during diastole oreven slightly less than a measured commissure-to-commissure width of thevalve during systole, such that the coaptation assist body fits withinthe valve without being excessively distorted or impinged upon along itslateral edges. Nonetheless, the width of the coaptation assist body willtypically be adequate to induce sealing of the valve. In some cases, thecoaptation assist body may be only a portion of a measured valve width,which could be as small as 75% or even 60%.

The implants described herein will often be deployable from a lumen of atrans septal or other atrial access catheter, an outer profile of thecatheter deployment system typically being less than 19 Fr, often beingless than 16 Fr, in many cases being 14 Fr or less. The coaptationassist body may be deployable by removing the coaptation assist bodyfrom within the surrounding deployment catheter and laterally expandingthe coaptation assist body from an insertion profile to a deployedprofile. The coaptation assist body may expand laterally by unfurling,unfolding, and/or unrolling the coaptation assist body. In someembodiments, the coaptation assist body has an insertion volume withinthe deployment catheter and a deployed volume greater than the insertionvolume, with the body volumetrically expanding within the heart so as toincrease a thickness of the coaptation assist device between the firstand second coaptation surfaces after it is removed from the catheterlumen. The coaptation assist body may comprise a permeable material, andmay be configured to volumetrically expand without resorting toinflating the coaptation assist body using inflation fluid introducedfrom outside a vascular system of the patient. In other embodiments,balloon-inflation like expansion may be used, or the coaptation assistbody may have an insertion volume within the deployment catheter, andthe implant may be configured so as to inhibit mal-coaptation withoutvolumetrically expanding the coaptation assist body from the insertionvolume. In some embodiments, and particularly where the mal-coaptationof the valve varies along the curve prior to implantation (for example,when there is prolapse of a segment of the mitral valve such as A2-P2),the variation in mal-coaptation along the curve may be characterizedusing imaging (such as ultrasound imaging, fluoroscopy, angiography,computer tomography, magnetic resonance imaging, or the like). Athickness of the deployed coaptation assist body between the firstcoaptation surface and the second coaptation surface may vary along thecurve in response to the characterization of the variation inmal-coaptation, optionally by selecting of an appropriate valve bodyfrom among a plurality of alternative valve bodies in response to thecharacterization.

The use of at least partially independent anchors separated about thetissues of the heart and/or of mountingly coupling the valve body to theat least initially deployed anchors significantly facilitatesimplantation. Selectively deploying the first and second anchors may beperformed by directing the first anchor toward the first targetlocation, and directing the second' anchor (often after the first anchorhas been at least initially deployed and independently of the directingof the first anchor) toward the second target location. The directing ofthe first anchor can be performed by steering a steerable catheter bodyfrom outside the patient, and the directing of the second anchor can beperformed by steering the same steerable catheter body. The steerablecatheter body may support an electrode sensing surface, and anelectrogram may be sensed at candidate target locations when theelectrode sensing surface is connected externally to an electricalsignal recording device. Alternatively, the anchor itself may haveelectrical sensing capability and connected externally to an electricalsignal recording device, or both catheter body and anchor may haveelectrical sensing capability. The first and/or second target locationscan be sensed in response to the electrograms of the candidate targetlocation, such as by determining when the electrogram has a desiredsignal corresponding to one or more of the major structures of the heart(for example, a desired mix of atrial and ventricle signals to identifyaxial positioning relative to the valve annulus, with or without a mixof signals indicative of lateral positioning relative to the septum orother anterior/posterior structures. Tactile indications of the annulusand commissures may also be employed, optionally under ultrasound and/orfluoroscopic imaging.

The separate deployment of the anchors may also facilitate verificationthat adequate support will be provided. For example, the first anchormay be configured to be initially deployed while remaining coupled tothe deployment system, such as by keeping a torqueable body connected toa helical anchor after the anchor has been screwed into the heart tissuefrom within the heart. It will then be possible to determine that theinitially deployed first anchor is not satisfactory, such as by applyingtension to the connecting body, via electrogram signals transmitted fromthe anchor, or the like. The initially deployed first anchor can then bedisengaged from tissue of the heart, aligned with the first targetlocation, and re-deployed. It will then be relatively straightforward toverify that the first anchor deployment at the first target location isacceptable, and the initial deployment, moving, and verifying can all beperformed without disengaging the second anchor from the second targetlocation (either because it was not yet even initially deployed, or byleaving the second anchor in engagement with the target tissuethroughout the process).

The coaptation assist body to be implanted in a particular patient maybe selected from among a plurality of alternatively selectablecoaptation assist bodies included with the implantation system. Thealternative bodies may have differing geometries suitable for mitigatingmal-coaptation of differing patients, and may be selected forimplantation with the anchors into the patient, optionally after atleast one of the first and second anchors are at least initiallydeployed, such as in response to a measurement of a location,separation, or other characteristic of the deployed first and secondanchors. Some or all of the coaptation assist bodies may have flangesthat protrude laterally from the coaptation surface when the coaptationassist bodies are in their nominal or deployed configurations, which theflanges often being configured so as to inhibit leaflet prolapse. Thegeometries of the flanges will often differ among the coaptation assistbodies so as to facilitate mitigation of differing leaflet prolapsecharacteristics of different patients by selecting an appropriatecoaptation assist body for that patient, often in response to imaging ormeasurement of the heart. For example, flanges may protrude from theanterior and/or posterior coaptation surfaces, may have differingprotrusion lengths, surface shapes, and/or axial positions, may havediffering lateral widths and lateral positions, and the like.

The coaptation assist body may be supportingly coupled in vivo with thefirst and/or second anchors after the first and/or second anchors areinitially deployed. A third anchor may be configured to be deployed at athird target location axially offset from the first and second targetlocations, optionally within the left ventricle such as a region of theventricle of the heart between papillary muscles of the ventricle. Thethird anchor may be pre-mounted to the valve body, and or may otherwisebe configured to be advanced within the deployment system toward thethird target location after the first and second anchors are deployed,using either the same steerable catheter or a different steerablecatheter. The third anchor can be rigidly affixed to an apical portionof the coaptation assist body, with the body configured to accommodaterelative movement between the anchors during beating of the heart withdeformation (such as lateral flexing and/or axial resilient elongation)of the coaptation assist body In some embodiments, an axially resilientstructure and/or material such as a spring, a resilient polymer materialsuch as a silicone elastomer, or the like may couple the third anchor tothe apical portion of the coaptation assist body so as to accommodatethe relative movement between the anchors. Still further options mightbe provide, including supporting the coaptation assist body with thethird anchor via a tether coupling the third anchor to an apical portionof the coaptation assist body, and further comprising accommodatingrelative movement between the anchors during beating of the heart withresilient deformation of the coaptation assist body between the tetherand the first and second anchors.

Advantageously, the devices and systems described herein can allow aphysician to determine an effectiveness of the implant at mitigating themal-coaptation while a delivery catheter remains coupled to at least oneof the anchors and/or to the coaptation assist body. The catheter mayremain coupled to the anchors such that the catheter system does notimpose a significant load on the implant, such that the implant can beevaluated for effectiveness in substantially the position andconfiguration the implant will have once the catheter system isdecoupled and removed. If the desired results are not seen, thephysician can move and/or replace the coupled anchor, and/or can replacethe coaptation assist body while leaving at least another of the anchorsdeployed. While some exemplary anchor embodiments use a tissuepenetrating helical body having a helical axis configured for rotatingthe helical body about the helical axis so that helical body penetratesthe first target location from within the heart, a variety ofalternative anchors might be used. In some embodiments, the anchorsmight comprise suture, clips, staples, radiofrequency energy welds, orthe like, and may be used to mount the body to heart tissue within theheart in an open surgical approach, during a robotic or endoscopicprocedure, with access to the valve optionally being provided through apuncture or incision through the ventricular apex or atrial appendage,or the like. The implant will typically be configured so that, whendeployed, loads transmitted between the coaptation assist body andtissue of the heart allow the annulus of the heart valve to change indiameter by more than 10% with each beat of the heart. Despite thesesignificant size excursions, and despite the first and second anchorsbeing circumferentially separated around the annulus, the anchors mayeach support the deployed implant sufficiently independently of theother to inhibit subjecting any resilient (including super-elastic)anchor-anchor interconnecting structure to fatigue-related failureduring long-term implantation. Hence, the invention can be used as amitral leaflet coaptation enhancement device configured to be positionedwithin the mitral valve during a brief, minimally invasive procedure,and can improve valve function without requiring reshaping of all orpart of the mitral annulus, and without changing leaflet edge anatomy(such as by fusing leaflet edges or the like).

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1E schematically illustrate some of the tissues of the heartand mitral valve, as described in the Background section and below, andwhich may interact with the implants and systems described herein.

FIGS. 2A-2C illustrate a simplified cross-section of a heart,schematically showing mitral valve regurgitation related tomal-coaptation.

FIG. 2D schematically illustrates an exemplary embodiment of an implantdeployed within the mitral valve of FIG. 2C so as to mitigate themal-coaptation.

FIGS. 3A and 3B schematically illustrate components of an implantdelivery system for mitigation of mal-coaptation.

FIGS. 3C and 3D schematically illustrate a coaptation assist bodysupported by a steerable catheter, with the body in a laterally expandedconfiguration and in an insertion configuration for advancement througha lumen of a delivery sheath, respectively.

FIG. 3E schematically illustrate a set of alternatively selectable valvebodies for delivery to a valve and in-situ mounting to deployed anchors.

FIGS. 3F-3G2 schematically illustrate a side view and cross-sectionsthrough an exemplary coaptation assist body.

FIGS. 3H-3Q schematically illustrate attachment of the coaptation assistbody to anchors and varying geometries of alternatively selectablecoaptation assist bodies.

FIGS. 4A-4C schematically illustrate alternative interface structuresfor mounting coaptation assist bodies to tissues of the heart.

FIGS. 4D and 4E schematically show an axial or end view of an implanthaving an arcuate base and the same implant compressed for insertioninto a delivery catheter.

FIGS. 5A-5L schematically illustrate exemplary method steps fordeploying implants into the heart so as to mitigate mal-coaptation.

FIGS. 6A-6C schematically illustrate alternative coaptation assistimplants and their implantation within a mitral valve.

FIGS. 7A and 7B schematically illustrate alternative implant mountinginterface structures and methods, and show apposition of the leafletsagainst a movable and/or deformable coaptation assist body.

FIGS. 8A-8F illustrate exemplary components of a coaptation assistimplant, including sliding engagement between an elongate anchorcoupling body and the interface so as to facilitate in situ mounting ofthe coaptation assist body to the anchor.

FIG. 9 shows a coaptation device in accordance with embodiments.

FIGS. 10A and 10B show a coaptation assist body in relaxed and curvedpositions respectively, in accordance with embodiments.

FIG. 11 shows the coaptation device of FIG. 9 after deployment.

FIGS. 12A and 12B show an effect of the adjustment of the curvature ofthe coaptation assist body of FIG. 9.

FIG. 13 shows the device of FIG. 9 after deployment within a heart valveand after elements used in the deployment are removed.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention generally provides improved medical devices,systems, and methods, often for treatment of mitral valve regurgitationand other valve diseases. The implants described herein will generallyinclude a coaptation assist body (sometimes referred to herein as avalve body) which is within the blood flow path as the leaflets of thevalve move back and forth between an open-valve configuration (with theleaflets separated from valve body) and a closed-valve configuration(with the leaflets engaging opposed surfaces of the valve body). Thevalve body may structurally float or move within the annulus of thevalve during beating of the heart, and will be disposed between thenative leaflets to fill gaps between the coapting leaflet surfaces.Those gaps may be lateral (such as may be caused by a dilated leftventricle and/or mitral valve annulus) and/or axial (such as where oneleaflet prolapses or is pushed by fluid pressure beyond the annulus whenthe valve should close.

Among other uses, the coaptation assistance devices, implants, andmethods described herein may be configured for treating functionaland/or degenerative mitral valve regurgitation (MR) by creating anartificial coaptation zone within which each of the native mitral valveleaflets can seal. The structures and methods herein will largely betailored to this application, though alternative embodiments might beconfigured for use in other valves of the heart and/or body, includingthe tricuspid valve, valves of the peripheral vasculature, or the like.

Referring to FIGS. 1A-1E, there are several conditions or disease statesin which the leaflet edges of the mitral valve fail to apposesufficiently and thereby allow blood to regurgitate in systole from theventricle into the atrium. Regardless of the specific etiology of aparticular patient, failure of the leaflets to seal during ventricularsystole is known as mal-coaptation and gives rise to mitralregurgitation.

The fibrous annulus, part of the cardiac skeleton, provides attachmentfor the two leaflets of the mitral valve, referred to as the anteriorleaflet and the posterior leaflet. The leaflets are axially supported byattachment to the chordae tendineae. The chordae, in turn, attach to oneor both of the papillary muscles of the left ventricle. In a healthyheart, the chordae support structures tether the mitral valve leaflets,allowing the leaflets to open easily during diastole but to resist thehigh pressure developed during ventricular systole. In addition to thetethering effect of the support structure, the shape and tissueconsistency of the leaflets helps promote an effective seal orcoaptation. The leading edges of the anterior and posterior leaflet cometogether along a funnel-shaped zone of coaptation, with a lateralcross-section of the three-dimensional coaptation zone CZ being shownschematically in FIG. 1E.

Generally, mal-coaptation can result from either excessive tethering bythe support structures of one or both leaflets, or from excessivestretching or tearing of the support structures. Other, less commoncauses include infection of the heart valve, congenital abnormalities,and trauma.

Valve malfunction can result from the chordae tendineae becomingstretched, known as mitral valve prolapse, and in some cases tearing ofthe chordae or papillary muscle, known as a flail leaflet. Or if theleaflet tissue itself is redundant, the valves may prolapse so that thelevel of coaptation occurs higher into the atrium, opening the valvehigher in the atrium during ventricular systole. Either one of theleaflets can undergo prolapse or become flail. This condition issometimes known as structural mitral valve regurgitation.

In excessive tethering, the leaflets of a normally structured valve maynot function properly because of enlargement of or shape change in thevalve annulus: so-called annular dilation. Such functional mitralregurgitation generally results from heart muscle failure. And theexcessive volume load resulting from functional mitral regurgitation canitself exacerbate heart failure, ventricular and annular dilation, thusworsening mitral regurgitation.

The anterior and posterior mitral leaflets are dissimilarly shaped. Theanterior leaflet is more firmly attached to the annulus overlying thecentral fibrous body (cardiac skeleton), and is somewhat stiffer thanthe posterior leaflet, which is attached to the more mobile posteriorlateral mitral annulus. The coaptation zone between the leaflets is nota simple line, but rather a curved funnel-shaped surface interface. Thecommissures are where the anterior leaflet meets the posterior leafletat the annulus. As seen most clearly in the axial views from the atriumof FIGS. 1C and 1D, an axial cross-section of the coaptation zonegenerally shows the curved line CL that is separated from a centroid ofthe annulus CA as well as from the opening through the valve duringdiastole CO. In addition, the leaflet edges are scalloped, more so forthe posterior versus the anterior leaflet. The generally 3 scallops, orsegments, are referred to as the AI, A2, and A3, and PI, P2, and P3segments. Mal-coaptation can occur between one or more of these A-Psegment pairs, so that mal-coaptation characteristics may vary along thecurve of the coaptation zone CL.

Referring now to FIG. 2A, a properly functioning mitral valve MV of aheart H is open during diastole to allow blood to flow along a flow pathFP from the left atrium toward the left ventricle LV and thereby fillthe left ventricle. As shown in FIG. 2B, the functioning mitral valve MVcloses and effectively seals the left ventricle LV from the left atriumLA during systole, thereby allowing contraction of the heart tissuesurrounding the left ventricle to advance blood throughout thevasculature. However, as illustrated in FIG. 2C, in a patient sufferingfrom mitral valve regurgitation, mal-coaptation of the leaflets of themitral valve MV during systole allows blood to regurgitate or flowbackward relative to the intended flow path FP, decreasing theeffectiveness of the left ventricle compression.

Referring now to FIG. 2D, an exemplary embodiment of a coaptation assistimplant 10 has been deployed within heart H. Implant 10 includes acoaptation assist body 12 supported relative to the heart tissues bysupport interface structures, with the exemplary supports making use ofindependent anchors 14. Coaptation assist body or valve body 12 isconfigured and positioned so that the anterior leaflet of the mitralvalve coapts with a first coaptation surface of the valve body and theposterior leaflet of the mitral valve coapts with a second coaptationsurface, with the first and second surfaces being generally opposed sothat the valve body is disposed between the previously mal-coaptingleaflets. The implant helps mitigate gaps and any axial mismatch betweenthe leaflets when the valve is closed, and may also help reposition theclosed leaflets toward a more effectively sealing closed configurationsuch that the mal-coaptation of the heart valve is mitigated.

Still referring FIG. 2D, independent anchors 14 allow a single anchor tobe deployed at an associated target location within the heart withouthaving to concurrently orient another of the anchors toward a differenttarget location. The use of independent anchors also allows anindividual anchor to maintain positioning engagement with the targetlocation of the heart before another anchor is moved into alignment witha different target location, and/or allows an anchor to be moved intoalignment with a target location of the heart after another anchor hasbeen deployed without moving the deployed anchor, and regardless of thesize of the valve body, valve, and/or the like.

The deployed coaptation assist implants described herein may exhibit anumber of desirable characteristics. Generally, the deployed implantswill mitigate or help correct mitral regurgitation MR due tomal-coaptation, including mal-coaptation secondary to restricted leafletmotion (i.e., excessive tethering of the mitral support structuresincluding the papillary muscles and chordae tendineae.) Similarly, thedeployed implants may mitigate or help correct MR due to mal-coaptationsecondary to excessive leaflet motion such as associated with mitralvalve prolapse or flail leaflet. Exemplary embodiments need not rely onreshaping of the mitral annulus (such as by thermal shrinking of annulartissue, implantation of an annular ring prosthesis, and/or placement ofa cinching mechanism either above or beneath the valve plane, or in thecoronary sinus or related blood vessels). Advantageously, they also neednot disrupt the leaflet structure or rely on locking together or fusingof the mitral leaflets. Many embodiments can avoid reliance onventricular reshaping, and after implantation represent passiveimplanted devices with limited excursion which may results in an verylong fatigue life. Mitigation of mitral valve mal-coaptation may beeffective irrespective of which leaflet segment(s) exhibitmal-coaptation. The treatments described herein will make use ofimplants that are repositionable during the procedure, and evenremovable after complete deployment and/or tissue response begins or iscompleted, often without damaging the valve structure. Nonetheless, theimplants described herein may be combined with one or more therapiesthat do rely on one or more of the attributes described above as beingobviated. The implants themselves can exhibit benign tissue healing andrapid endothelialization which inhibit migration, thromboembolism,infection, and/or erosion. In some cases, the coaptation assist bodywill exhibit no endotheliazation but its surface will remain inert,which can also inhibit migration, thromboembolism, infection and/orerosion.

Referring now to FIGS. 3A-3C, components of a coaptation assist systemcan be seen. An anchor deployment catheter 100 includes an elongatecatheter body 101 having a proximal end 102 and a distal end 104, with alumen 106 extending therebetween. An anchor 108 is mounted to the distalend of an elongate anchor delivery body 110, allowing the anchor to beadvanced distally through lumen 106. In the exemplary embodiment, anchor108 comprises a helical body that can be deployed by torquing theproximal end of anchor delivery body 110 proximally of anchor deliverycatheter 100 so as to screw the anchor into the tissue of the heart fromwithin the atrium and/or ventricle, so that anchor 108 can be derivedfrom and/or analogous to a pacemaker lead. A wide variety of alternativeanchor structures might also be used.

Referring still to FIGS. 3A-3C, anchor deployment catheter 100 willtypically have a proximal handle 112 with an actuator 114 forselectively steering or bending catheter body 101 near distal end 104.By selectively steering catheter 100 and manipulating the handle 112 soas to rotate catheter body 101 and/or axially advance the catheter body,the lumen 106 can be oriented toward a target region within the heart.Catheter 100 may comprise any of a wide variety of know steerablecatheter structures, including those which include a pull wire extendingdistally from actuator 114 to distal end 104 so as to selectively bendand steer the catheter. In an exemplary embodiment, anchor deploymentcatheter 100 includes an electrode 116 adjacent distal end 104, with theelectrode being coupled to a proximal electrogram connector 118 by asignal conductor extending axially within catheter body 101, therebyallowing the physician to measure electrograms from candidate anchorlocations prior to deploying the anchor. Regardless of any electrogramsensing capability of the catheter system alone, use of a conductivesurface of an anchor (such as the outer surface of a metallic anchorstructure) as an electrode may advantageously provide signals directlyfrom the tissue, whereas the catheter structure may be positioned offthe tissue. Electrode 116 may also be used as a high-contrast markerunder any of a variety of imaging modalities so as to facilitate imageguidance of the anchor deployment.

Referring now to FIGS. 3C and 3D, a valve body deployment catheter 120releasably carries a valve body 122 near a distal end 124. Valve body122 is seen expanded in its nominal or deployed configuration in FIG.3C, and with a reduced profile for insertion into a lumen 126 of anouter deployment sheath 128, with the deployment sheath being and lumenbeing shown schematically. Valve body delivery catheter 120 has aproximal handle 130 and may again be steerable so as to direct an anchor108 mounted to valve body 122 toward a target location. Catheter body132 of valve body delivery catheter 120 (or a torquable shaft within thecatheter body) may be rotationally and axially coupled to anchor 108 soas to facilitate deployment of the anchor from outside the patient.

Valve body 122 in its nominal or deployed configuration may have anatrial or proximal end 134 and a ventricular or distal end 136, as seenin FIGS. 3C-3F. The valve body may be laterally flexible, (optionallycomprising one or more sheets or layers of a flexible tissue-ingrowth orendothelialization matrix such as an expanded polytetrafluoroethylene(ePTFE)) in a roughly triangular configuration, with opposed lateraledges 138 tapering radially inwardly toward the distal end 136 andanchor 108 of the valve body. Alternative valve body materials can alsobe used including valve bodies formed using allograft and/or xenograftmaterials, artificial collagenous matrices, alternative polymermaterials, or the like. The valve body may include more than onematerial, including fibers or layers of materials which alter themechanical characteristics such as to reinforce an ingrowth orendothelialization material, increase or decrease a modulus ofelasticity, or the like, with the altered characteristics optionallybeing provided uniformly or along selected portions of the valve body. Alateral atrial support 140 may be provided, but will often not be reliedupon as the primary structure to maintain engagement of the anchorsagainst the tissues of the heart to which they are attached. In theembodiment shown, atrial support 140 may comprise one or moreplastically and/or resilient flexible polymer filament such as a sutureor the like, one or more filament of a superelastic shape memory alloysuch as a Nitinol alloy, one or more superelastic polymer filament, orthe like. The atrial end 134 of valve body 122 may slidingly engageatrial support or member 140 so as to facilitate laterally compressingthe valve body into outer sheath 13 8. The ends of atrial support 140may each include a loop 142 or other structure to slidably engage anelongate anchor delivery body 110 of an associated anchor 108 (see FIGS.3A and 3B), as will be more fully understood with reference to thedescription of the steps that can be used during deployment of theimplant as provided below.

As seen in FIG. 3E, exemplary embodiments of coaptation assist systemsmay include a set 150 having plurality of alternatively selectable valvebodies, with the various valve bodies 122, 122 a, 122 b, . . . oftenhaving differing geometries. Each valve body 122 will typically have anominal and/or deployed axial length 152 (with the axial lengthgenerally being measured along the axis of the valve when the valve bodyis positioned for use), a lateral width between lateral edges 138, and athickness 154 between the opposed major surfaces 156, 158 of the valvebody. Each of the native leaflets of the valve will coapt with anassociated one of the major surfaces 156, 158 of the valve body 122, sothat these surfaces may also be referred to herein as coaptationsurfaces. The varying geometries of the various valve bodies 122, 122 a,122 b, . . . of valve body set 150 will typically include differingthicknesses 154 (so as to accommodate differing mal-coaptationcharacteristics), differing axial lengths 152 (so as to accommodatediffering ventricle geometries), differing lateral widths between thelateral edges 138 (so as to accommodate differingcommissure-to-commissure arcuate distances, differing cross-sectionalcurvatures (so as to accommodate differences in the curvature linedefined by the coaptation zone of the valve), and/or the like. Selectingfrom among these differing geometries by picking an associated one ofthe set of valve bodies 150 allows tailoring of the mitral valveregurgitation therapy to the valve disease of a particular patient.Advantageously, the selection of the valve body from the set may also bedone after (and in response to) deployment of one or more of theanchors, so that the selected valve body and its associated structuralinterface may make use of the deployed anchors as measurement fiducialsfor measuring the valve, and may also be tailored to be suitable for theactual anchor positions within the patient.

Referring now to FIGS. 3G1 and 3G2, schematic axial cross-sections ofvalve body 122 show an outer tissue ingrowth layer 170 disposed alongthe opposed major surfaces 156, 158 over a fluid-absorbing core 172.Core 172 can have a small volume configuration prior to implantation (asshown in FIG. 3G2) in which the core has a significantly smaller volumethan after core 172 has been deployed within the heart and absorbedfluid. Suitable materials for core 172 may comprise foams includingmedical grade polyurethane foam, silicone and/or natural rubber foam,hydrogels, a wide variety of hydrophilic polymer matrices, or the like.Core 172 and outer layer 170 may together define a nominalcross-sectional shape of the valve body (including a valve body curve174) when the valve is unconstrained and absorbs blood or anothersuitable model fluid. As the valve body will often be a relativelyconformable structure with a geometry that can be altered by interactionwith tissues, the deployed cross-sectional shape of the valve body (andthe overall three-dimensional valve body shape) will often depend onboth the nominal shape, the surrounding cardiac tissue, and thecharacteristics (locations and the like) of the anchors.

Referring now to FIGS. 3H, 3I1, and 3I2, the deployed implant 180 willoften support valve body 122 using structural support interfaces thatinclude anchors 108 along with associated structural mountings orcouplers 182 so as to facilitate in situ assembly of the valve body andat least one of the anchors. Couplers 182 are shown schematically, butmay comprise simple loops or apertures in atrial support 140 or elongateanchor coupling body 110 that allows one of these two structures toslide relative to the other. By sliding a loop 142 of atrial support 140over a proximal end of elongate anchor coupling body 110 (for example)outside the patient, the atrial support and valve body may be guideddistally by deployment body 110 into engagement with the deployed anchor108. The structural engagement between the deployed anchor and valvebody can optionally be completed by crimping the loop closed around theelongate anchor coupling body 110 adjacent the anchor, by advancing alocking structure over the elongate anchor coupling body so as thecapture the loop between the anchor and locking structure, by capturingthe loop into a latch of the anchor, or by another suitable coupler 182.Once the valve body is supported by the anchor as desired, the elongateanchor coupling body proximal of the connector 182 can be detached andremoved. Also shown schematically in FIGS. 3H and 3I1 are axial struts184 which can be included within valve body 122 so as to inhibit axialbending, thereby enhancing coaptation when the coaptation zone between afirst leaflet of the valve and major surface 156 is axially offset fromthe coaptation zone between a second leaflet of the valve and surface158.

Referring now to FIGS. 3I3-3I2, an exemplary anchor deployment assembly402 includes an anchor coupling body 110 and the associated anchor 108,along with an anchor deployment catheter 404. Anchor deployment catheter404 includes an elongate shaft with a proximal portion 406 extendingdistally to a more flexible distal portion 408. A distal tip of theflexible portion includes a torque-imparting feature such as a slot 410to releasably rotationally drive anchor 108 when a transverse memberacross the helical coil of the anchor axially engages the distal end ofanchor deployment catheter (such as when the elongate coupling body 110proximal of anchor catheter 404 is pulled proximally), allowing theanchor to be rotationally and axially driven into tissue by manipulatingthe proximal end of the anchor deployment catheter.

The structure and use of an exemplary anchor crimping and cuttingassembly 420 can be understood with reference to FIGS. 3I6-3I9. Acrimping and cutting catheter 422 includes a shaft 424 that extendsdistally from a proximal handle 426. A distal portion of shaft 424 ismore flexible than a proximal portion, and ends at a distal tip 428having a side port 430 and releasably supporting a crimp 432. Crimp 432receives anchor coupling body 110 therethrough, with crimp featuresconfigured (such as by being biased radially inwardly, having proximallyoriented edges, and/or the like) to allow the coupling body to slideproximally through the crimp but to inhibit distal movement of thecoupling body relative to the crimp. A distally oriented surface ofcrimping and removal catheter 420 engages the crimp, allowing the crimpto be advanced distally along the coupling body 110 by pushing handle426 distally and/or pulling the coupling body from outside the patient.Once crimp 432 engages (or is sufficiently close to) anchor 108, acutting knob 434 adjacent handle 426 can be actuated so as to advance acutting member such as a blade 440 and sever elongate body 110 adjacentanchor 108, as can be understood with reference to FIGS. 3I7 and 3I8.Crimping and cutting catheter 420 can then be decoupled from crimp 432and anchor 108 by withdrawing the handle proximally, as shown in FIG.3I9. Note that crimp 432 will often be used to affix an implant toanchor 108 by advancing the implant over the coupling body 110 prior toadvancing 432 distally.

An alternative crimping and cutting assembly 420′ and associated methodcan be understood with reference to FIGS. 3I10-3I13, with the assemblyhere having an alternative cutting member 440′ coupled to an energysource 444. Energy source 444 may comprise an ultrasound energy source,a laser energy source, an RF or other electrical energy source, or thelike, so that energizing of the cutting member by the energy sourcefacilitates decoupling of the elongate body 110 from the anchor. Notethat a wide variety of alternative decoupling and/or cutting systemsmight be employed, including systems derived from those used to decoupleembolism coils and the like. Similarly, a variety of crimping or otheranchor/valve body coupling mechanisms may be employed, and a separatecrimp catheter structure and cutting catheter structure could be used ifdesired.

Referring now to FIGS. 3I14-3I17, it can be seen how an aperture throughlateral atrial support 140 can be disposed over elongate connectorbodies 110 between the anchors 108 and crimps 432, capturing the atrialsupport and thereby providing a coupler 182 that mounts the valve body122 to the anchors. Additional details regarding an exemplaryventricular coupler 182 that can be used to affix the ventricularportion of coaptation body 122 to the ventricular anchor 108 can also beseen. More specifically, a hub 450 includes an outer collar and a pin452 extending laterally therethrough. Ventricular anchor 108 extendsaxially through hub 450, with the helical winds of the anchor passingabove and below pin 452. A torquable feature such as a socket 454removably engages a driving feature 456, allowing an anchor deploymentshaft 458 to rotate the helical anchor from outside the patient througha delivery catheter or sheath 128. As can be understood by comparing theventricular anchors of FIGS. 3I17 and 3I18, interaction between pin 452of hub 450 and the helical coils of anchor 108 during rotation of theanchor drives the anchor distally, facilitating advancement into tissueof the ventricle.

Referring now to FIG. 3I18, an implant having an alternative andoptionally less traumatic ventricular anchor 460 is shown. Anchor 460comprises a central shaft 462 and a circumferential array of radiallyprotruding arms 464, with the arms angling proximally when in a nominalor deployed configuration. Arms 464 of anchor 460 may be resilientlycompressed inwardly for delivery or advancement within tissue of theventricle, with the arms optionally retaining the anchor in the hearttissue like barbs, with the arm structures comprising a relatively highstrength metal such as a Nitinol alloy, or a high strength polymer. Inexemplary embodiments, anchor 460 need not penetrate deeply into thetissue of the heart wall, but can be advanced so that arms 464 lesstraumatically entangle with the ventricular trabeculae. Such embodimentsmay employ relatively flexible arm materials and configurations, withthe arms optionally comprising relatively soft tines of a polymer suchas polyurethane, polyester, nylon, or the like.

Referring now to FIGS. 3J-3L, the alternative geometries of the valvebodies 122, 122 a, 122 b, . . . may include differing localizedvariations in thickness 154 between major surfaces 156, 158. Mitralvalve regurgitation may be localized, for example, with a large amountof malcoaptation between valve leaflet segments A1/P1 (see FIG. 1B) sothat a relatively thick valve body would be advantageous in those areas,while the coaptation zone along the interface between segments A2/P2 andA3/P3 would not benefit from as thick a valve body (and for which toothick of a valve body may even be deleterious). Valve bodies 122, 122 x,122 y . . . have variations in thickness 154 between lateral edges 13 8,and selection of an appropriate one of these differing geometries willenhance coaptation. Advantageously, if a first valve body does notprovide effective sealing along one or more leaflet segments wheninitially deployed, that valve body may be removed and replaced with analternative valve body having greater thickness at those segments,generally without having to alter a position of initially deployedanchors adjacent the valve annulus.

Referring now to FIGS. 3M-3Q, still further alternative geometries ofthe valve body can be seen, with the valve bodies here having differingflanges along an atrial portion of one or both of the coaptationsurfaces so as to mitigate prolapse. In the valve body embodiment 468 ofFIG. 3M, a fold or flange 470 protrudes laterally from an adjacentconcave coaptation surface 472 so as to axially engage an atrial portionof an anterior facing leaflet. The engagement between flange 470 and theleaflet may help configure the leaflet and/or valve body, enhancingsealing of the valve. Valve body embodiment 474 of FIG. 3N has aprotruding fold or flange on a concave or posterior facing side, whichmay help mitigate prolapse of the other leaflet. Still furthercoaptation assist bodies may have flanges or folds that are localizedalong a lateral portion of their widths, with the localized lip beingconfigured to inhibit upward prolapse of one or more of the leafletsegments. For example, in the embodiments of FIGS. 3O and 3P, valvebodies 480 and 482 have localized lips 484 and 486 protruding from theirconcave coaptation surface 488 and convex coaptation surface 490,respectively, with FIG. 3Q showing a cross-section of the valve body 480a shape of lip 484.

Referring now to FIGS. 4A and 4B, a variety of alternative or modifiedsupport interfaces structures may be employed to transfer loads betweenthe valve body and the surrounding tissues of the heart. For example, inFIG. 4A, valve body 122 is coupled to ventricle anchor 108 by an axiallyresilient spring 190, so that the spring can help accommodate relativeaxial motion between the anchors adjacent the valve annulus and the moreapically disposed ventricular anchor. In FIG. 4B, valve body 122 isaxially supported by the ventricular anchor 108 via a laterally flexiblefilament or tether 192. An atrial tether 196 may support atrial end 134of the valve body, with the atrial tether in turn optionally beingsupported by a left atrial appendage anchor 198. Left atrial appendageanchor 198 may optionally comprise a radially expandable body havingbarbs, so that the anchor can be expanded into affixed engagement withthe left atrial appendage of the heart.

Still further alternative or additional anchor structures and structuralinterface approaches may be employed. An arcuate support base 202 may beconfigured to extend along the annulus of the valve for alternativeimplant 204 as shown in FIGS. 4C-4E. Base 202 has a plurality of tissuepenetrating barbs 206 to penetrate tissue and affix the base relative tothe valve annulus. Connectors 182 may slidingly couple valve body 122 tobase 202. The exemplary arcuate base structure can be compressed withina lumen of a delivery catheter as shown in FIG. 4E, with the arcuatebase preferably extending axially of at least a portion of the valvebody. As with the other embodiments described herein, a hub mayoptionally couple valve body 122 with anchor 108 (in some embodimentsvia a tether 192 or spring, in other embodiments with the hub affixingthe anchor relative to the adjacent valve body before, during, and/orafter deployment). When the ventricular anchor comprises a helix, theanchor may be rotatable with respect to the valve body, with the huballowing relative rotation between the anchor and valve body duringdeployment. The hub may comprise a suture or ePTFE tube.

The coaptation assistance devices described herein are often configuredfor transvascular delivery and/or deployment via minimally invasivesurgery (e.g. thoracotomy, transapical, via the left atrial appendage(LAA), or the like), with delivery and placement preferably being inbetween or adjacent to the cardiac valve's native leaflets. Inparticular, the valve can be one of the AV valves such as the tricuspidvalve and/or the mitral valve. The drawings and exemplary embodimentslargely relate to the mitral valve, but analogous methods and devicescan be applied to the tricuspid valve. The coaptation assistance body ofthe implant can often be delivered by a delivery catheter and may becapable of expanding from a smaller profile to a larger profile todimensions appropriate for placement in between the valve's nativeleaflets. In some embodiments, the implants may also find applicationsfor treatment of nonnative valve leaflets (for example, after valvereplacement) or for treatment after the native leaflets have previouslybeen surgically modified.

The leaflet-apposing valve body element may comprise self expandablematerials such as medical grade polyurethane foam and may be coveredwith a material such as ePTFE. The valve body may optionally include orbe affixed to (or otherwise mountable on) a self expandable frame, withthe frame optionally comprising a plurality of members includingresiliently (including super-elastically) deformable materials such as aNitinol alloy. Other frame materials may include stainless steel,plastics, etc. Other materials for the covering include polyurethanes,biologic tissue such as porcine pericardium, silicone, etc. In otherembodiments, the leaflet-apposing valve body element may comprise aself-expandable structure such as a Nitinol alloy frame and covered withbiocompatible material such as ePTFE. In yet other embodiments theleaflet-apposing element and/or the support interfaces may comprise abraided structure appropriately shaped and covered with ePTFE to fillthe gap between the incompetent (mal-coapting) leaflets.

The entire implant and/or valve body, or portions thereof, mayincorporate a radiopaque material or an echo-enhancement material forbetter visualization. The leaflet-apposing valve body element may have asymmetrical or asymmetrical cross section to create an optimalcoaptation surface, with the cross-section preferably corresponding to(and/or depending on) the anatomy of the leaflets and theirmal-coaptation. The leaflet apposing valve body element may include acurve biased toward a prolapsing leaflet to provide structural supportfor the prolapsing leaflet and inhibit prolapsing of the leaflet so asto mitigate mal-coaptation. The leaflet apposing valve body element maybe printed with a radio-opaque material such as radio-opaque ink. Anysupport structures of the valve body or support interface having a framemay be coated with radio-opaque materials such as gold or platinum orimpregnated with barium. The leaflet apposing valve body element may becoated with an echo enhancement material.

The coaptation assistance device or implant may include one or aplurality of atrial anchors to stabilize the device and/or a ventricularanchor, with the anchors optionally providing redundant fixation. Theatrial anchor or anchors may attach to or adjacent the annulus. Theannular anchor, if it is included, may be covered with biocompatiblematerials such as ePTFE to promote endothelialization and, optionally,chronic tissue in-growth or encapsulation of the annular anchor foradditional stability. Furthermore the annular anchor may include aplurality of barbs for acute fixation to the surrounding tissue. Inother embodiments, the atrial anchors may comprise a plurality ofhelixes, clips, harpoon or barb-shaped anchors, or the like, appropriatefor screwing or engaging into the annulus of the mitral valve, tissuesof the ventricle, and/or other tissues of the atrium, or the atrial orventricular anchors may attach to the tissue by welding using RF energydelivered via the elongate anchor coupling body 110. The ventricularanchor may comprise a helix rotatable with respect to the leafletapposing element and connected to the hub of the leaflet apposingelement by a suture or ePTFE tube. In some embodiments, a ventricularanchor may be included in the form of a tether or other attachment meansextending from the valve body thru the ventricle septum to the rightventricle, or thru the apex into the epicardium or pericardium, whichmay be secured from outside the heart in and combined endo/epiprocedure. When helical anchors are used, they may comprise bio-inertmaterials such as Platinum/Ir, a Nitinol alloy, and/or stainless steel.As noted above, in some embodiments, an atrial anchor in the form of anexpandable structure for placement in the left atrial appendage may beincluded. In still further embodiments, an atrial anchor and supportinterface may be included in the form of a flexible line or tetherattached to an atrial septal anchor. The atrial septal anchor may beconfigured like a transseptal closure device, optionally usingstructures that are well known. Any left atrial appendage anchor oratrial septal anchor may be covered with a biocompatible material suchas ePTFE, silicone, Dacron, or biologic tissue, or fixed in place usingRF welding. A left atrial appendage anchor or atrial septal anchor maybe connected to the leaflet apposing valve body element with suture, orePTFE tube, or may comprise a pre-shaped and rigid or resilient materialsuch as a Nitinol alloy.

The delivery system may include a delivery catheter, with exemplarydelivery catheters comprising a variable stiffness shaft with at leastone through lumen, the shaft configured for deflecting along at least adistal section. The delivery catheter may further include a controlhandle to manipulate the device anchors and to manipulate the dockingand undocking of the device with the delivery catheter. The controlhandle may further include flush, irrigation and aspiration ports toremove the air from the system and allow injection of fluids such assaline or contrast media to the site of implantation. The deliverysystem may also include at least one torque shaft or other elongateanchor coupling body for manipulating the device anchors, initiallydeploying and recapturing of the anchors to and from the deliverycatheter, and guiding the valve body distally to one or more of theinitially deployed anchors.

The delivery system may also include an outer sheath or introducer,typically to allow the introduction of the delivery catheter through alumen of the outer sheath and into the left atrium, so that the outersheath functions as a trans septal sheath. The transseptal sheath mayinclude a variable stiffness outer shaft with at least one lumen, thelumen sized to allow insertion of the delivery catheter and/orcoaptation assistance body through the sheath lumen. A deflectabledistal section of the trans septal sheath may facilitate alignment ofthe coaptation assistance device with the valve leaflets.

A conductive surface of the catheter system and/or implant may becoupled by a conductor to a proximal end of the delivery system so as toallow the conductive surface to act as an electrode, for example, tohelp to detect the location and/or deployment characteristics of animplant. The transseptal catheter and/or delivery catheter may includeat least one electrode at the distal tip configured to be connected toan intracardiac electrogram sensing and/or recording system. In someembodiments, an electrogram may be sensed from the anchor 108, providingan electrogram signal that can be transmitted along the elongate anchorcoupling body 110. Anchor coupling body 110 can be coupled with anappropriate electrogram recording system. Unipolar electrogram signalssensed at the electrode on the distal end or the delivery catheter, aunipolar electrogram sensed at the anchor 108, and/or a bipolarelectrogram recorded between the delivery catheter electrode and theanchor, can be used to evaluate candidate locations for deployment ofthe anchor or other implant components. In particular the annulus of thevalve may be detected by an appropriate ratio of atrial electrogramsignals to ventricular electrogram signals at a candidate location. Oncea signal ratio in a desired range has been identified (for example, witha ratio of about 1:2), the information from the signal may be combinedwith imaging information showing that the candidate location is near acommissure of the annulus, and in response, the candidate sight may beselected as an anchoring site for an associated atrial anchor.

Referring now to FIGS. 5A-5L, exemplary method steps which may beincluded in embodiments of methods for treatment of mitral valveregurgitation associated with malcoaptation can be understood. Note thatrelated method steps may also be used for other indications and/or fortherapies of other valves. Prior to treatment (and optionally againduring and/or after treatment), surgical staff may evaluate the anatomyof the heart and/or the components thereof (including the mitral valve),and may chose an appropriate configured implant. The evaluation caninclude x-ray, CT, MRI, and 2 d or 3 d echocardiography and the like.

Referring first to FIG. 5A, a transseptal method for treatment of MRwill often include gaining access to the left atrium LA via atransseptal sheath 300. Access to the femoral vein may be obtained usingthe Seldinger technique. From the femoral vein, access can then beobtained via the right atrium to the left atrium by a trans septalprocedure. A variety of conventional trans septal access techniques andstructures may be employed, so that the various imaging, guidewireadvancement, septal penetration, and contrast injection or otherpositioning verification steps need not be detailed herein. Exemplarysteerable transseptal sheath 300 has an elongate outer sheath body 302extending between a proximal handle 304 to a distal end 306, with thehandle having an actuator for steering a distal segment of the sheathbody similar to that described above regarding deployment catheter 100.A distal electrode and/or marker near the distal end 306 of sheath body302 can help position the sheath within the left atrium. In someembodiments, an appropriately sized deflectable trans septal sheathwithout steering capability 310 may be guided into position in the leftatrium by transseptal sheath 300 (see FIG. 5B) or may be advanced intothe left atrium without use of a steerable transseptal sheath.Alternatively, deployment may proceed through a lumen of the steerablesheath 300. Regardless, an outer access sheath will preferably bepositioned so as to provide access to the left atrium LA via a sheathlumen.

Referring now to FIG. 5B, deployment catheter 100 is advanced throughthe outer trans septal sheath and into the left atrium. The distal endof the deployment catheter moves within the left atrium by manipulatingthe proximal handle and by articulating the actuator of the handle so asto selectively bend the distal end of the catheter body, bringing thedistal end of the catheter into alignment and/or engagement withcandidate locations for deployment of an anchor, optionally underguidance of 2D or 3D intracardiac, transthoracic, and/or transesophagealultrasound imaging, Doppler flow characteristics, fluoroscopic or X-rayimaging, or another imaging modality. Electrode 116 at the distal end ofdeployment catheter 100 optionally senses electrogram signals andtransmits them to an electrogram system EG so as to help determine ifthe candidate site is suitable, such as by determining that theelectrogram signals include a mix of atrial and ventricular componentswithin a desired range (such as within an acceptable threshold of 1:2).Contrast agent or saline may be introduced through the deploymentcatheter. Before, during, and/or after the deployment catheter is beingpositioned in engagement with and/or oriented toward an acceptabletarget location, an anchor 108 is advanced distally through a lumen ofthe deployment catheter, so that the advanced anchor extends from thepositioned catheter and into engagement with tissue of the heart at thetarget location, with advancement of the anchor preferably beingperformed using an elongate anchor coupling body 110 and an anchorcatheter 404 of anchor deployment assembly 402. An electrogram may berecorded from the anchor 108 via the elongate anchor coupling body 110to further assist in identifying an acceptable target location.

As can be understood with reference to FIGS. 5B, 5C, and 3I3-3I5 a firstatrial anchor 108 is preferably deployed into the mitral valve annulusby axially advancing the anchor and rotating the helical anchor bodythrough the positioned deployment catheter, screwing the helical bodypenetratingly into the heart tissue using elongate anchor coupling body110 and anchor catheter 404. Deployment catheter 100 and anchor catheter404 can then be retracted proximally from deployed anchor 108, leavingthe anchor affixed to the tissue and associated elongate anchor couplingbody 110 extending proximally from the anchor and out of the body. Notethat anchor 108 may remain only initially deployed at this stage, as itcan be recaptured, removed, and/or repositioned by torquing the elongateanchor coupling body so as to unscrew the helical anchor body. As can beunderstood with reference to FIGS. 5B and 5C, deployment catheter 100can be removed from the outer transseptal sheath 310 leaving elongateanchor coupling body 110 in place (with the deployment catheter alsobeing withdrawn proximally from over the elongate anchor coupling bodyso that the anchor coupling body is no longer within the deploymentcatheter lumen, but remains within the outer transseptal sheath lumen).As seen in FIG. 5E, the deployment catheter 110 can then be re-inserteddistally through the outer sheath lumen (alongside the elongate anchorcoupling body of the deployed anchor) and into the left atrium.

Referring now to FIGS. 5E and 5F, deployment catheter 100 may bemanipulated and/or steered so as to engage the tip of the catheter with(and/or orient the tip toward) a second target location. In theexemplary embodiment, the first and second target locations are near thetwo opposed commissures of the mitral valve. Sensing of electricalsignals, remote imaging, tactile indications of tissue structures, andthe like can be used for positioning, as generally described above. Oncedeployment catheter 100 appears to be in place, a second anchor 108′ isdeployed using a second elongate anchor body 110′ and associated anchorcatheter. As can be understood with reference to FIGS. 5F and 5G,deployment catheter 100 can be withdrawn proximally over second elongateanchor body 110′ and out of outer sheath 310, leaving both anchors 108,108′ deployed and both associated elongate anchor deployment bodies 110,110′ extending from the deployed anchors through the outer sheath sothat their proximal ends are outside the body of the patient.Advantageously, anchors 108, 108′ can be used as measurement fiducialsto facilitate measurement of the valve, valve and/or anchor movement,anchor positioning relative to the valves, and the like usingmeasurement capabilities of a remote imaging system 320. Elongate anchordeployment bodies 110, 110′ can also be used to verify anchor deploymentand/or to verify anchor sites on the valve annulus by pulling proximallyon the deployment bodies, measuring a electrogram signal from an anchorelectrode, and/or the like. If desired, one or both atrial anchors canbe re-deployed as described above.

Referring now to FIGS. 5H and 5I, a guidewire 330 is advanced throughtrans septal sheath 310 into the left atrium. Guidewire 330 crosses themitral valve and is advanced distally into the left ventricle, as shownin FIG. 5I. Valve body 122 is loaded on guidewire 330, in the exemplaryembodiment by passing the guidewire through a helical lumen of helicalventricle anchor 108″. Valve body 122 is also loaded onto elongateanchor deployment bodies 110 110′ by passing each of the bodies throughan associated one of loops or apertures 142, 142′ of atrial member 140,so that an orientation of any nominal curvature of valve body 122corresponds to the curved line defined by a cross-section of thecoaptation zone of the mitral valve. Valve body 122 can be inserted intotrans septal sheath 310 and advanced into the left atrium. In theexemplary embodiments, valve body 122 is advanced distally by passingelongate guide bodies 110, 110′ and guidewire 330 proximally through thelumen of anchor deployment catheter 100 or a separate valve bodydeployment catheter 340. Valve body deployment catheter 340 is describedabove with reference to catheter 120 of FIGS. 3C and 3D. Ventricleanchor 108″ engages a distal surface at the distal end of deploymentcatheter 340 so as to allow the deployment catheter to push theventricle anchor 108″ and attached valve body 122 distally into andalong the lumen of outer sheath 310, as can be understood with referenceto FIGS. 5I and 5J. Loops or apertures 142, 142′ slide distally alongthe elongate anchor deployment bodies 110, 110′ as the valve bodyadvances.

As can be understood with reference to FIGS. 5J and 5K, deploymentcatheter 340 is manipulated and/or articulated so as to advance valvebody 122 distally out of septal sheath 310 and within the left atrium asso that ventricular anchor 108″ and distal portion of valve body 122cross the mitral valve. Catheter 340, guidewire 330, anchor deploymentshaft 458 or another torque-transmission shaft may rotationally engageventricular anchor 108″, and a hub between the ventricular anchor andvalve body 122 may allow relative rotation about the helical axis asdescribed above. Tension applied by pulling the proximal ends ofelongate anchor deployment bodies 110 while advancing deploymentcatheter 340 brings the anchors into engagement with the remainingcomponents of the structural interface between valve body and thetissues (such as loops or apertures 142 and atrial member 140). Thepositions of anchors 108, 108′ help orient valve body 122 within thevalve so that edges 138 are each oriented toward an associatedcommissure, and so that the leaflets each coapt with an associated majorsurface 156, 158 of the valve body. A desired amount of axial tensioncan be applied to valve body 122 by applying a distal load on deploymentcatheter 340, and the deployment catheter can be manipulated and/orarticulated into engagement with a candidate location of the ventricle,optionally between the papillary muscles. The candidate location can beverified as generally described above, and catheter 340 or anothertorque-transmitting anchor driving shaft can be rotated whilemaintaining the distal end of ventricle anchor 108″ in contact with thetarget location so that the helical anchor body penetrates into tissueof the ventricle, thereby deploying the valve body. In alternativeembodiments, an atraumatic ventricular anchor 460 can be deployed byadvancing the anchor and/or withdrawing a surrounding sheath from overthe anchor) so that the arms of anchor engage with the highly unevensurface of the ventricular trabeculae, and so that the arms of theanchor are entangled therein sufficiently to restrain the position ofthe anchor within the ventricle. Note that embodiments of such an anchorneed not be configured to penetrate significantly into the ventricularwall (although alternative barbed anchor embodiments can).

Advantageously, hemodynamic performance of the valve with the valve bodytherein can be evaluated before decoupling one or more of the anchorsfrom the delivery catheter system (and in some embodiments, even beforethe ventricle anchor is deployed in ventricle tissue). If results areless than desired, one or more of the anchors can be detached from thetissue and retracted back into the transseptal sheath 310, allowing thephysician to reposition the anchor and coaptation assistance body. Thevalve body can be withdrawn proximally via sheath 310 and an alternativevalve body selected, loaded into the sheath, and deployed ifappropriate. One or more of the atrial and/or ventricular anchors can beredeployed and the surgical staff can again perform a hemodynamicevaluation. In some embodiments, one or more of guidewire 330 and/orelongate anchor deployment bodies 110, 110′ may remain coupled to anassociated anchor for hours or even days. Once the implant is in thedesired deployed configuration, the device may be locked to the elongateanchor deployment bodies or tethers using crimps, or knots, etc., andthe excess lengths of these bodies may be cut and removed from theimplant. In the exemplary embodiments, crimps 432 can be advanceddistally using one or more crimping and cutting assembly 420 or 420′ soas to affix the valve body to the deployed atrial anchors, and elongatebodies 110 can be decoupled from the anchors, as can be understood withreference to FIGS. 5K, 5L, and 3I7-3I13. If the deployment is deemedacceptable, after deploying the ventricular anchor and after the implantis released from the catheter system, the surgical staff can remove theremaining catheter system components and elongate anchor deploymentbodies.

A full hemodynamic evaluation—e.g. intra cardiac echocardiogram (ICE),trans esophageal echocardiogram (TEE) or transthoracic echocardiogram(TIE) may be performed on the patient after deployment is complete.

Referring now to FIGS. 6A-7B, a variety of alternative supportstructures might be employed so as to help maintain a position and/ororientation of valve body 122, with or without anchors 108 or 260. Forexample, implant embodiments similar to that described above regardingFIG. 4B may include an atrial support tether 196 configured to helpaxially support valve body 122, with the tether optionally being affixedto tissue of the left atrial appendage LAA using an expandable leftatrial appendage anchor 198, as seen in FIG. 6A. Leaflet prolapse orother forms of mal-coaptation 502 of the mitral valve MV may bemitigated by supporting valve body between the leaflets, optionallyusing a ventricular tether 504 anchored near a ventricular apex of leftventricle LV and/or an arcuate support structure 506 disposed along theannulus of the valve, as can be understood with reference to FIGS.6B-7B. Prior to deployment of the implant, mal-coaptation leads tomitral regurgitation during ventricular systole, but does notsignificantly impede free flow of blood from the atrium into theventricle during diastole, particularly when the cross-section of theimplant remains substantially aligned along the flow of blood. As can beunderstood by comparing FIGS. 6C and 7A, the shape of the ventricleand/or annulus may change significantly during each heart cycle, so thatarcuate anchor 506 and ventricular tether 504 may flex significantlyduring each heart beat. Implant life can be impacted by such flexing,which should be considered when selecting an appropriate anchor system.As can be understood with reference to FIGS. 6B and 7B first and secondcoaptation zones 510,512 between each leaflet of the valve and valvebody 122 may be slightly (or even significantly) axially offset fromeach other, particularly when the implant is used to treatmal-coaptation related to prolapse of one leaflet.

Additional aspects of the present invention can be understood withreference to FIGS. 8A-8F. FIG. 8A shows a prototype triangular valvebody formed from a uniform sheet of ePTFE, along with atrial andventricular anchors. Sliding engagement between the valve body and anatrial member, and between loops or apertures of the atrial member andelongate deployment bodies of the atrial anchors can be seen in FIGS. 8Band 8F. Passing of a ventricular guidewire through a helical lumen ofthe helical anchor is shown in FIG. 8C, and the anchors and some of thedeployment system components which interact therewith can be seen inFIG. 8D. FIG. 8E shows an expanded configuration of the valve body andthe anchor deployment structures as the valve body is advanced out of atransseptal sheath.

Still further aspects of the present invention can be understood withreference to FIGS. 9-13. The embodiments of FIGS. 9-13 may provideadditional adjustability of the valve body, so that the valve body canbe adapted to a patient's particular physiology, and may provideadditional improvement in the treatment of mal-coaptation. FIG. 9 showsa coaptation device 900 in accordance with embodiments. Coaptationdevice 900 is introducible into the heart and coupleable in vivo withinthe heart valve to be treated, in a manner similar to that describedabove. Coaptation device 900 includes a coaptation assist body 901,which further includes a first major coaptation surface 902, and asecond major coaptation surface not visible in FIG. 9. Coaptation assistbody 901 has an axis, for example a longitudinal axis generally runningfrom an upstream end 903 to a downstream end of coaptation assist body901. Other axes may be defined, for example a transverse axis. Examplecoaptation assist body 901 also defines an axial channel 904, and atether 905 is disposed within channel 904. Tether 905 may be a wire orsuture, or may be made of another suitable material, and is preferablycoupled to coaptation assist body 901 at downstream end 903.

As is visible FIGS. 10A and 10B, channel 904 and tether 905 arepreferably positioned asymmetrically or eccentrically within coaptationassist body 901, that is, not coincident with the neutral bending axisof coaptation assist body 901, such that as the length of tether 905within coaptation assist body 901 is varied, the curvature of coaptationassist body 901 changes. For example, FIG. 10A shows coaptation assistbody 901 in a relaxed position, and FIG. 10B shows coaptation assistbody 901 is a more curved position. A curvature lock 1001 is disposed atthe one end (in this case upstream end 902) of coaptation assist body901. In the example shown, curvature lock 1001 is a crimp that can becrimped onto tether 905, to lock tether 905 such that the distancebetween ends 902 and 903 of coaptation assist body 901 is constrained,to define a curvature of coaptation assist body 901. Once curvature lock1001 is engaged and tether 905 is locked, tether 905 may be cut and theunused portion removed, as shown in FIG. 11.

Referring again to FIG. 9, coaptation assist device 900 may includevarious anchors for anchoring coaptation assist device 900 within theheart valve. A central atrial anchor 906 may be deployable to anchorcoaptation assist body 901 near upstream end 902, for example to theannulus of the heart valve in the atrium of the heart. One or morelateral atrial anchors 907 a, 907 b may be affixed near the lateraledges of upstream end 902 of coaptation assist body 901, and may bedeployable to fix upstream end 902 to the heart near respectivecommissures of the heart valve. A ventricular anchor 908 may be affixednear downstream end 903, and may be deployable to fix downstream end 903to ventricular tissue of the heart.

An effect of the adjustment of the curvature of coaptation assist body901 is shown in FIGS. 12A and 12B. In FIG. 12A, insufficient curvaturehas been introduced, and an opening 1201 exists between coaptationassist body 901 and valve leaflet 1202, such that valve regurgitationmay still occur. In FIG. 12B, more curvature has been introduced suchthat valve leaflet 1202 contacts coaptation assist body 901 at location1203, and may reduce or prevent valve regurgitation. In FIGS. 12A and12B, coaptation assist body 901 is shown in the process of being fixedwithin the heart valve via a catheter 1204 extending thought the fossaovalis 1205.

FIG. 13 shows the system after installation within the heart valve, oncecurvature lock 1001 has been crimped onto tether 905 and the unusedportion of tether 905 has been removed. Anchors 906 and 908 are alsovisible in FIG. 13, anchoring coaptation assist body 901 within theheart valve.

In other embodiments, a system and method are provided for treatingmal-coaptation of a heart valve in a patient. The system may include acoaptation assist device such as or similar to coaptation assist device900, in conjunction with a catheter system through which the coaptationassist device may be deployed within the heart valve.

In an exemplary method of treating mal-coaptation of a heart valve in apatient, an implant, for example coaptation assist device 900, isintroduced into the heart valve. The introduction may be through acatheter system as described above. For example, the catheter system mayinclude a guide catheter or sheath such as sheath 301, and one or moredelivery catheters for delivering the coaptation assist body, anchors,and other items into the heart. In one application, a coaptation assistbody such as coaptation assist body 901 is positioned in the coaptationzone between the anterior and posterior leaflets of the mitral valve.The coaptation assist body may be introduced in a first configurationand deployed in a second configuration. For example, the coaptationassist body may be furled for travel through the catheter system, andunfurled for deployment within the heart valve. The method may includeanchoring an upstream end of the coaptation assist body to the annulusof the heart valve, and may also include anchoring the downstream end ofthe coaptation assist body to ventricular tissue of the heart.

Once the coaptation assist body is disposed within the heart valve, itscurvature may be adjusted. For example, once the atrial and ventricularanchors are in place, a crimp delivery catheter may be advanced into theheart and a tether such as tether 905 may be tensioned to cause thecurvature of the coaptation assist body to change by changing thedistance between the upstream and downstream ends of the coaptationassist body. Once the desired curvature is set, a lock such as crimp1001 may be engaged to constrain the distance between the upstream anddownstream ends of the coaptation assist body. When the installation iscomplete, the excess tether may then be cut away, and the cathetersystem removed. The crimping and cutting may be accomplished in a mannersimilar to that discussed above and illustrated in FIGS. 3I6-3I9.

Preferably, the surgeon implanting the device is provided with sensoryinformation about the beating heart during at least part of theinstallation of the coaptation assist device. For example, anechocardiogram may provide feedback as to the amount of valveregurgitation that is occurring, so that the surgeon can select theoptimum amount of curvature of the coaptation assist body to mitigate,minimize, or eliminate the regurgitation.

While exemplary embodiments have been described in some detail forclarity of understanding, a variety of adaptations and modification willbe clear to those of skill in the art. For example, access to the leftatrium can be provided at least in part via a minimally invasive entryin the left atrial appendage or thru the left ventricular apex.Additionally, as the devices and methods described herein may be faster,less skill dependent, and/or suitable for sicker patients thanalternative valve treatments (that often involve larger access systemsor are otherwise more traumatic), and as the implants described hereinmay be temporarily deployed, these techniques may be used as a short orintermediate-term therapy, giving patients time and allowing recovery soas to be better able to tolerate an alternative treatment. Thesetechniques may also be suitable for re-treatment of patients that havepreviously had valve therapies. These techniques may also be appropriatefor placement in positions at the mitral valve in a patient undergoingcoronary artery bypass grafting. Hence, the scope of the presentinvention is limited solely by the following claims.

1-20. (canceled)
 21. A method for treating mal-coaptation of a heartvalve of a heart of a patient, the heart valve comprising an annulus andfirst and second leaflets, the method comprising: introducing an implantinto the heart while the implant is in a first configuration; deployingthe implant from the first configuration to a second configurationwithin the heart, the implant in the second configuration comprising acoaptation assist body with a first surface and a second surface opposedto the first surface; anchoring the implant in a position in which thefirst surface is in position to coapt with the first leaflet of theheart valve; and wherein the coaptation assist body moves and/or deformssignificantly to help maintain natural movement of tissues of the heart.22. The method of claim 21, wherein the coaptation assist body generallyremains within a blood flow path of the heart valve as the first andsecond leaflets move back and forth between an open valve configurationand a closed valve configuration.
 23. The method of claim 21, wherein asthe heart valve opens during diastole, the coaptation assist body isconfigured to move with the flow.
 24. The method of claim 21, wherein asthe heart valve opens during diastole, the coaptation assist body isconfigured to move like a middle leaflet.
 25. The method of claim 21,wherein as the heart valve opens during diastole, the coaptation assistbody is configured to move like a sail around which the blood passes.26. The method of claim 21, wherein the coaptation assist body isconfigured to move with movement of tissues of the heart to which thecoaptation assist body is anchored.
 27. The method of claim 21, whereinas the heart valve moves from an open valve configuration toward aclosed valve configuration, movement of the first leaflet and the secondleaflet facilitates movement of the coaptation assist body back into aconfiguration for sealing.
 28. The method of claim 21, wherein as theheart valve moves from an open valve configuration toward a closed valveconfiguration, movement of tissues of the heart to which the coaptationassist body is anchored facilitates movement of the coaptation assistbody back into a configuration for sealing.
 29. The method of claim 21,wherein as the heart valve moves from an open valve configuration towarda closed valve configuration, movement of blood facilitates movement ofthe coaptation assist body back into a configuration for sealing.
 30. Amethod for treating mal-coaptation of a heart valve in a patient, theheart valve having an annulus and first and second leaflets, the methodcomprising: introducing an implant into the heart while the implant isin a first configuration; deploying the implant from the firstconfiguration to a second configuration within the heart, the implant inthe second configuration comprising a coaptation assist body with afirst surface and a second surface opposed to the first surface;anchoring the implant in a position in which the first surface is inposition to coapt with the first leaflet of the heart valve; and whereinthe coaptation assist body comprises a triangular configuration withopposed lateral edges tapering radially inwardly toward a ventricularend.
 31. The method of claim 30, further comprising deployingindependent anchors near each of the two commissures.
 32. The method ofclaim 30, further comprising deploying additional anchors configured tofacilitate positioning and support of the coaptation assist body. 33.The method of claim 30, wherein the coaptation assist body comprises oneor more sheets or layers.
 34. The method of claim 30, wherein thecoaptation assist body comprises an outer surface comprising ePTFE. 35.A method for treating mal-coaptation of a heart valve in a patient, theheart valve having an annulus and first and second leaflets, the methodcomprising: introducing an implant into the heart while the implant isin a first configuration; deploying the implant from the firstconfiguration to a second configuration within the heart, the implant inthe second configuration comprising a coaptation assist body with afirst surface and a second surface opposed to the first surface;anchoring the implant in a position in which the first surface is inposition to coapt with the first leaflet of the heart valve; and whereinthe coaptation assist body swells toward a nominal three-dimensionalshape after introduction into the heart.
 36. The method of claim 35,wherein the coaptation assist body comprises multiple layers.
 37. Themethod of claim 35, wherein the coaptation assist body is configured tomove with tissues of the heart.
 38. The method of claim 35, whereindeploying the implant comprises placing the implant into a patient'sbeating heart.
 39. The method of claim 35, wherein deploying the implantcomprises positioning the implant in alignment with the heart valvewithout open heart surgery.
 40. The method of claim 35, whereindeploying the implant comprises deploying via a patient's vasculatureusing a catheter deployment system.